WELLVONE Atovaquone 750mg/5mL oral liquid suspension bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

atovaquone, Quantity: 150 mg/mL

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Oral Liquid, suspension

Composition:

Excipient Ingredients: poloxamer; saccharin sodium; benzyl alcohol; purified water; xanthan gum; Flavour

Administration route:

Oral

Units in package:

210mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Wellvone suspension is indicated for: Acute treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) (difference of alveolar and arterial oxygen tensions [(A-a)DO2]<=45mmHg(6kPa) and oxygen tension in arterial blood (Pa02)>=60mmHg(8kPa) breathing room air) in adult patients with AIDS who are intolerant of trimethoprim/sulphamethoxazole therapy.

Product summary:

Visual Identification: Bright yellow suspension with a sweet, fruity odour.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1998-12-07

Patient Information leaflet

1
WELLVONE ORAL LIQUID SUSPENSION
_Atovaquone _
CONSUMER MEDICINE INFORMATION
Patient's Name
First Address Line
Second Address Line
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you start Wellvone
Suspension.
This leaflet answers some
common questions about
Wellvone Suspension. It does not
contain all of the available
information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Wellvone
Suspension against the benefits
this medicine is expected to have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT WELLVONE
SUSPENSION IS USED
FOR
Atovaquone the active ingredient
in Wellvone Suspension belongs
to a group of medicines called
anti-infectives.
Wellvone Suspension is used to
treat a type of pneumonia (lung
infection) caused by _Pneumocystis _
_carinii_.
_Pneumocystis carinii_ is a parasite
that can lie dormant in the airways
unless the body’s immune system
becomes weakened, for example
in human immunodeficiency virus
(HIV) infection. This can lead to
_Pneumocystis carinii_ pneumonia
(PCP).
Wellvone Suspension works by
interfering with important functions
within _Pneumocystis carinii_.
Your doctor may have prescribed
Wellvone Suspension for another
reason.
Ask your doctor if you have any
questions about why Wellvone
Suspension has been prescribed
for you.
This medicine is available only
with a doctor’s prescription.
Wellvone Suspension is not
addictive.
BEFORE YOU TAKE
WELLVONE SUSPENSION
_ _
_WHEN YOU MUST NOT TAKE IT _
•
DO NOT TAKE WELLVONE
SUSPENSION IF YOU HAVE EVER
HAD AN ALLERGIC REACTION TO
ATOVAQUONE OR ANY OF THE
INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
Symptoms of an allergic
reaction may be mild or
severe. They usually include
some or all of the following:
wheezing, swelling of the
lips/mouth, difficulty in
breathing, hayfever, lumpy
rash ("hives") or fa

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
WELLVONE (ATOVAQUONE) ORAL LIQUID SUSPENSION
1
NAME OF THE MEDICINE
Atovaquone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
WELLVONE oral liquid suspension contains the active atovaquone 750 mg
in 5 mL.
Excipient with known effect: saccharin.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
WELLVONE suspension is bright yellow with a sweet fruity odour.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
WELLVONE Suspension is indicated for:
Acute treatment of mild to moderate _ Pneumocystis carinii _ pneumonia
(PCP) (difference of
alveolar and arterial oxygen tensions [(A-a) DO
2
]
≤
45 mmHg (6 kPa) and oxygen tension in
arterial blood (Pa0
2
)
≥
60 mmHg (8 kPa) breathing room air) in adult patients with AIDS who
are
intolerant of trimethoprim/sulphamethoxazole therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The importance of taking the full prescribed dose of WELLVONE with
food should be stressed to
patients. The presence of food, particularly high-fat food, increases
bioavailability two to three
fold.
Shake well before use. Do not dilute.
DOSAGE IN ADULTS
_Pneumocystis carinii pneumonia: _
The recommended oral dose of WELLVONE suspension is 750 mg (5 mL)
administered with food
twice
daily
for
21
days
(see
Pharmacokinetics
in
Adults).
For
patients
with
difficulty
in
swallowing and unable to take two meals a day, the dose should be
1,500 mg (2 x 5 mL) with food
once a day for 21 days.
DOSAGE IN CHILDREN
Experience with WELLVONE in the paediatric population shows it to be
well tolerated, but data
are limited to a pharmacokinetic and safety study and at present there
is insufficient data to
recommend the use of atovaquone in children (see 4.4 Special Warnings
and Precautions for use,
Paediatric Use).
2
DOSAGE IN ELDERLY
There
have
been
no
studies
of
WELLVONE
in
the
elderly
(see
4.4
Special
Warnings
and
Precautions for use, Use in the Elderly).
4.3
C
ONTRAINDICATIONS
WELLVONE
suspension
is
contra-indicated
in
individuals
with
known
hyperse